Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics.

Zachary P SmithM WilkinsonC CarneyN GroveB QutabK Getz

Published in: Therapeutic innovation & regulatory science (2021)

This study presents advancement and refinement in measuring participation burden that will assist drug development teams and protocol authors in retrospectively understanding clinical trial performance outcomes and in prospectively informing protocol design decisions.

Keyphrases

clinical trial
randomized controlled trial
physical activity
metabolic syndrome
cardiovascular disease
risk factors
study protocol
weight loss
skeletal muscle
phase iii